510(k) K201520 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
The Alma Opus System, Colibri Applicator and Tips
| Applicant | Alma Lasers, Inc., Buffalo Grove IL, US |
| Decision | Substantially Equivalent, Oct 27, 2021 |
| Received | Jun 8, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201520
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.